Electrical Control of Bladder in Spinal Cord Injury Patients | NCT00011570

Studies
Electrical Control of Bladder in Spinal Cord Injury Patients

NCT00011570

Sponsor

US Department of Veterans Affairs

Status

Completed

Last Update Posted

Apr 28, 2008Estimated

Enrollment

18Estimated

Phase

Phase 2

Conditions

Spinal Cord Injury

Interventions

Bladder & Bowel Control

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1998

Primary Completion Date

Oct 2005Actual

Completion Date

Nov 2007Actual

First Submitted Date

Feb 22, 2001

First Submission Date that Met QC Criteria

Feb 23, 2001

First Posted Date

Feb 26, 2001Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2008

Last Update Posted Date

Apr 28, 2008Estimated

Description Module

Brief Summary

The investigators will continue their work with implanted stimulators to improve bladder and bowel function. Electrical stimulation produces simultaneous contraction of sphincters with the target organs, making emptying difficult. By optimizing electrode placement, employing a new electrode design and waveform choice, it is hoped to improve the 50% of subjects able to defecate with existing approaches. This is part of a multi-center study with multiple support sources, including Rehab R&D, PVA and a commercial stimulator company.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Estimated

Label	Type	Description	Intervention Names
1	Other		Device: Bladder & Bowel Control

Name	Type	Description	Arm Group Labels	Other Names
Bladder & Bowel Control	Device		1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Spinal cord injury with bowel & bladder problems

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Donald Bodner, MD	VA Medical Center-Cleveland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VA Medical Center, Cleveland		Cleveland	Ohio	44106	United States

Condition Browse Module

MeSH Terms

ID	Term
D013119	Spinal Cord Injuries

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided